Device Classification Name |
console, heart-lung machine, cardiopulmonary bypass
|
510(k) Number |
K002116 |
Device Name |
S3 CARDIOPLEGIA CONTROL MODULE VERSION 2.0 |
Applicant |
MEDICAL DEVICE CONSULTANTS, INC. |
49 PLAIN ST. |
NORTH ATTLEBORO,
MA
02760 -4153
|
|
Applicant Contact |
CYNTHIA J NOLTE |
Correspondent |
MEDICAL DEVICE CONSULTANTS, INC. |
49 PLAIN ST. |
NORTH ATTLEBORO,
MA
02760 -4153
|
|
Correspondent Contact |
CYNTHIA J NOLTE |
Regulation Number | 870.4220
|
Classification Product Code |
|
Date Received | 07/13/2000 |
Decision Date | 08/09/2000 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|